CXR4 Computed Tomography XRay System

  • Modèle / numéro de série
    The recalled CXR4 system units are identified with the following Code Numbers: CXR46201 through CXR4622 and CXR4624 through CXR46244.
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Nationwide distribution, including Puerto Rico (PR).
  • Description du dispositif
    Hitachi CXR4 Computed Tomography (CT) Scanners, Software Version 1.51 or less.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Hitachi Medical Systems America Inc, 1959 Summit Commerce Park, Twinsburg OH 44087
  • Société-mère du fabricant (2017)
  • Source
    USFDA